US20150180161A1 - Implantable medical electrical leads and connector assemblies thereof - Google Patents
Implantable medical electrical leads and connector assemblies thereof Download PDFInfo
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- US20150180161A1 US20150180161A1 US14/133,899 US201314133899A US2015180161A1 US 20150180161 A1 US20150180161 A1 US 20150180161A1 US 201314133899 A US201314133899 A US 201314133899A US 2015180161 A1 US2015180161 A1 US 2015180161A1
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Images
Classifications
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
- H01R13/46—Bases; Cases
- H01R13/52—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases
- H01R13/5224—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases for medical use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3752—Details of casing-lead connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R24/00—Two-part coupling devices, or either of their cooperating parts, characterised by their overall structure
- H01R24/58—Contacts spaced along longitudinal axis of engagement
Definitions
- the present disclosure pertains to implantable medical electrical leads, and more particularly to constructions of lead connector assemblies that are configured to mate with connector receptacles of corresponding implantable medical devices.
- Implantable medical systems for example, those providing electrical stimulation for cardiac or neurological therapy, often include a pulse generator device and an elongate medical electrical lead that extends from the device to a stimulation site in a body of a patient.
- Implantable medical electrical lead connectors Numerous configurations of implantable medical electrical lead connectors have been disclosed over the years, many of which are directed toward compliance with international industry standards; these standards specify essential dimensions and performance requirements to assure compatibility of connection between pulse generator device connector receptacles and lead connectors among a variety of manufacturers.
- One such standard dictates the form for a four-pole in-line connector of cardiac pacing and defibrillation leads and is commonly known as the IS-4 or DF-4 standard.
- FIG. 1A is a plan view of an exemplary implantable medical electrical lead 100 , which includes a connector assembly 120 and a terminal connector pin 110 that protrudes proximally from a proximal end 121 of assembly 120 to form an in-line connector in conformance with the aforementioned DF-4 standard.
- FIG. 1A illustrates lead 100 including a low voltage distal-most electrode lde, a first high voltage stimulation electrode hse 1 , and a second, optional, high voltage stimulation electrode hse 2 .
- Distal-most electrode lde may be part of a passive fixation assembly, known in the art, as illustrated, or part of an active fixation assembly, which is also known in the art, and stimulation electrodes hse 1 , hse 2 may each be formed from tantalum or platinum coils that extend around an insulative body 130 of lead 100 .
- Dashed lines in FIG. 1A represent elongate conductors 301 , 302 , 303 , wherein a dot on each electrode represents an electrical coupling between each conductor 301 - 303 and a corresponding electrode lde, hse 1 , hse 2 ; conductors 301 - 303 extend within lead body 130 , through a connector transition zone 140 and into connector assembly 120 .
- Lead body 130 and transition zone 140 are configured to electrically isolate conductors 301 - 303 from one another and may be formed from medical grade silicone and/or polyurethane.
- the coupling of each electrode lde, hse 1 , hse 2 to the corresponding conductor 301 , 302 , 303 may be formed by any suitable method known in the art, for example, laser welding and/or crimping.
- FIG. 1A also shows a dot on connector pin 110 and on each of contact surfaces cs 1 -cs 3 to represent an electrical coupling with the corresponding conductor 301 - 303 .
- conductor 301 couples distal-most electrode lde to connector pin 110
- conductor 302 couples stimulation electrode hse 1 to both first and second contact surfaces cs 1 , cs 2 , such that lead 100 provides integrated bipolar pacing and sensing via electrodes lde and hse 1 , in addition to high voltage defibrillation stimulation via electrode hse 1 (and electrode hse 2 , by the coupling to contact surface cs 3 , if electrode hse 2 and the corresponding conductor 303 are included).
- Sealing surfaces ss 1 , ss 2 , ss 3 , ss 4 are shown extending between connector pin 110 and contact surface cs 1 , between contact surfaces cs 1 and cs 2 , between contact surfaces cs 2 and cs 3 , and between contact surface cs 3 and transition zone 140 , respectively.
- pin 110 and contact surfaces cs 1 -cs 3 are configured to mate with device contacts mounted within a connector receptacle of the device, and sealing surfaces ss 1 -ss 4 are configured to mate with sealing rings, which are interspersed between the contacts within the device connector receptacle, so that an electrical coupling is made between each device contact and the corresponding pin/contact surface, within the receptacle, and these couplings are electrically isolated from one another by the sealing rings.
- pin 110 and first contact surface cs 1 are designated low voltage contacts
- second and third contact surfaces cs 2 , cs 3 are designated high voltage contacts.
- the DF-4 standard also requires a specific configuration of terminal connector pin 110 and a uniform outer diameter D of connector assembly 120 . If lead 100 does not include second stimulation electrode hse 2 and corresponding conductor 303 , the DF-4 standard still requires the presence of third contact surface cs 3 , albeit inactive, to preserve the standard form of connector assembly 120 . According to FIG. 1A , first contact surface cs 1 and second contact surface cs 2 of exemplary lead 100 are electrically common with one another for the aforementioned integrated function of electrode hse 1 (e.g., to function as a low voltage pace/sense electrode and as a high voltage stimulation electrode). However, with reference to FIG.
- lead 100 is reconfigured to include another low voltage electrode for true bipolar pacing and sensing in conjunction with distal-most electrode lde, for example, a ring electrode le shown extending around lead body 130 , just proximal to electrode lde, another conductor (not shown) extends within lead body 130 , and electrically couples low voltage electrode le to first contact surface cs 1 .
- second conductor 302 is only electrically coupled to second contact surface cs 2 , and first and second contact surfaces cs 1 and cs 2 are not electrically common, being isolated from one another.
- a connector assembly for an implantable medical electrical lead which are disclosed herein, include an insulation segment and a conductor segment, wherein, according to some embodiments, the insulation segment includes first and second sealing surfaces and the conductor segment includes first and second contact surfaces and a shank, which extends distally from the second contact surface, and which is electrically common with the first and second contact surfaces.
- the insulation and conductor segments may be formed together in a molded subassembly.
- the first sealing surface extends distally from a proximal end of the connector assembly
- the first contact surface extends between the first and second sealing surfaces
- the second contact surface extends distally from the second sealing surface, wherein an entirety of each of the sealing surfaces and of each of the contact surfaces define a uniform outer diameter of the connector assembly, which uniform outer diameter conforms to a requirement (e.g., an industry standard) for mating with a connector receptacle of an implantable medical device.
- the shank of the conductor segment has an outer diameter that is smaller than the uniform outer diameter of the assembly and is sized to receive a coiled proximal end of a conductor of the lead mounted thereabout for coupling to the connector assembly.
- the shank may be divided into a proximal portion and a distal portion, for example, by a flange of the shank, wherein the coiled proximal end of the conductor is mounted around the distal portion of the shank, and an insulative overlay extends around the proximal portion of the shank, for example, to provide an interface for a bond that joins the shank to another insulation segment, according to some construction embodiments.
- the other insulation segment includes a third sealing surface and an inner surface that extends beneath the third sealing surface and around the overlay for bonding thereto, such that an entirety of the third sealing surface also defines the uniform outer diameter of the connector assembly.
- a medical electrical lead with integrated bipolar pacing and sensing includes the above-described connector assembly and a terminal connector pin, which protrudes from the proximal end thereof, being engaged within a proximal lumen of the connector assembly, wherein a first conductor of the lead is coupled to the pin and extends distally therefrom through the proximal lumen of the connector assembly and through a lumen of the shank, and a second conductor of the lead has the aforementioned coiled proximal end that is coupled to the connector assembly.
- the lead further includes a distal-most electrode, which is coupled to a distal end of the first conductor, and a stimulation electrode, which is coupled to a distal end of the second conductor.
- the above-described connector assembly further includes a third contact surface that is part of another conductor segment, wherein the aforementioned insulation segment that includes the third sealing surface also includes a fourth sealing surface, and the third contact surface extends between the third and fourth sealing surfaces.
- the other conductor segment and the corresponding insulation segment may be formed in a molded subassembly, according to some construction embodiments, and the shank of the above-described molded subassembly is nested beneath the third sealing surface, for bonding thereto, as described above.
- this connector assembly that includes the third contact surface is incorporated by the above-described bipolar medical electrical lead, the third contact surface is inactive and electrically isolated from the conductors of the lead.
- the other conductor segment further includes a distal shank that is electrically common with the third contact surface and extends distally therefrom, beneath the fourth sealing surface.
- the distal shank has an outer diameter that is smaller than the uniform outer diameter of the assembly, and is sized to receive a coiled proximal end of an elongate conductor of the lead mounted thereabout for coupling thereto.
- a tripolar lead includes a third conductor and a corresponding stimulation electrode, in addition to the two electrodes and corresponding conductors described above, wherein the third conductor has the coiled proximal end coupled to the distal shank, and the distal shank includes an inner surface that defines a lumen through which the aforementioned second conductor extends to the coiled proximal end thereof, which is mounted about the other shank.
- a proximal subassembly of the connector assembly includes a first sealing surface, which extends distally from the proximal end of the connector assembly, a first contact surface, which extends distally from the first sealing surface, a first junction portion, which extends distally from the first contact surface, and a first shank, which extends distally from the first junction portion.
- a middle subassembly of the connector assembly includes a second sealing surface, a second contact surface, which extends distally from the second sealing surface, a second junction portion, which extends distally from the second contact surface, and a second shank, which extends distally from the second junction portion.
- the second sealing surface of the middle subassembly is bonded to the first junction portion of the proximal subassembly and abuts the first contact surface.
- a distal subassembly includes a third sealing surface and a third junction portion, wherein the third sealing surface is bonded to the second junction portion of the middle subassembly and abuts the second contact surface, and the third junction portion is configured for a junction with an insulative sleeve of the medical electrical lead.
- An entirety of the each of the first, second, and third sealing surfaces and of each the first and second contact surfaces define the uniform outer diameter of the connector assembly.
- Each of the first and second shanks is integrally formed and electrically common with the corresponding contact surface; and each of the first and second junction portions is integrally formed with the corresponding sealing surface in a corresponding bulk of insulative material.
- the first shank of the proximal subassembly extends within a lumen of the middle subassembly; and the second shank of the middle subassembly extends within a lumen of the distal subassembly.
- Embodiments of the connector assembly further include a first coiled conductor, which is mounted around and coupled to the first shank of the proximal subassembly, and a second coiled conductor, which is mounted around and coupled to the second shank of the middle subassembly.
- FIG. 1A is a plan view of an exemplary implantable medical electrical lead
- FIG. 1B is a plan view of a distal portion of another exemplary implantable medical lead
- FIGS. 2A-C are a plan view, an end view, and a cross-section view, respectively, of a portion of a connector assembly, according to some embodiments;
- FIG. 3 is an exploded perspective view of the connector assembly, according to some embodiments.
- FIG. 4A is a cross-section view of another portion of the connector assembly, according to some embodiments.
- FIG. 4B is a cross-section view of the connector assembly including the portion shown in FIG. 4A and assembled around an inner assembly of a medical electrical lead, according to some embodiments;
- FIG. 5 is a perspective view of another portion of the connector assembly, according to some alternate embodiments.
- FIG. 6 is an exploded perspective view of a connector assembly, according to some alternate embodiments.
- FIGS. 2A-C are a plan view, an end view, and a longitudinal cross-section view, respectively, of a proximal subassembly 210 , according to some embodiments, which extends along a longitudinal axis 2 , and which may be a portion of a connector assembly, like connector assembly 120 ( FIG. 1 ). It should be noted, that although portions of exemplary embodiments of the present invention are described in the context of connector assembly 120 , which conforms to the DF-4 standard, alternate embodiments of the present invention may include some of the described portions, without others, and need not conform to the DF-4 standard.
- FIG. 2B includes section lines A-A and B-B, wherein the cross-section view of FIG.
- FIGS. 2A and 2C illustrate subassembly 210 including an insulation segment 25 and a conductor segment 27 , wherein insulation segment 25 includes first sealing surface ss 1 and second sealing surface ss 2 , and conductor segment includes first contact surface cs 1 , second contact surface cs 2 , and a shank 278 , which extends distally from second contact surface cs 2 and is electrically common with first and second contact surfaces cs 1 , cs 2 .
- FIGS. 2A and 2C further illustrate an entirety of each of the first and second sealing surfaces ss 1 , ss 2 and each of the first and second contact surfaces cs 1 , cs 2 defining the aforementioned uniform outer diameter D, which may be approximately 3.2 mm (0.126 inch).
- insulation segment 25 is a bulk of insulative material, for example, a relatively hard plastic, such as Polyether ether ketone (PEEK), polyurethane, or polysulfone, that is injection molded around conductor segment 27 , wherein conductor segment 27 is a metallic component, for example, having been machined from medical grade stainless steel or MP35N alloy, such that first and second contact surfaces cs 1 , cs 2 and shank 278 are integrally formed.
- PEEK Polyether ether ketone
- conductor segment 27 is a metallic component, for example, having been machined from medical grade stainless steel or MP35N alloy, such that first and second contact surfaces cs 1 , cs 2 and shank 278 are integrally formed.
- an original outer diameter of portions of the metal component which correspond to contact surfaces cs 1 , cs 2 , is larger than the uniform outer diameter D, so that recessed grooves in a mold cavity can hold the component in place while the aforementioned insulative material is injection molded thereabout.
- subassembly 210 is ground down, for example, via a centerless grinding process known in the art, to the uniform outer diameter D.
- a diameter of shank 278 is smaller than diameter D, and, with reference to FIG. 3 , is sized to receive a coiled proximal end 312 of an elongate conductor coil mounted thereabout, for coupling to first and second contact surfaces cs 1 , cs 2 .
- the smaller outer diameter of shank 278 has a tapering profile 208 , for example, to facilitate the mounting of coiled proximal end 312 thereabout.
- coiled proximal end 312 is an integral extension of conductor 302 , or, according to some alternate embodiments, coiled proximal end 312 is coupled to conductor 302 within transition zone 140 , according to any suitable method known in the art.
- FIGS. 2A , 2 C and 3 further illustrate an insulative overlay, which extends around a proximal portion of shank 278 , and which is divided into a first part 26 A and a second part 26 B.
- This overlay is preferably separately formed from the same insulative material as insulation segment 25 , wherein overlay first part 26 A provides a junction portion, or an interface for bonding another part of the connector assembly, for example, a distal subassembly 320 ( FIGS. 3 and 4B ), to subassembly 210 , and overlay second part 26 B provides a junction portion for attachment of an insulative sleeve 430 ( FIG.
- FIGS. 2A and 2C illustrate shank 278 including a flange 207 , according to some embodiments, that separates the proximal portion thereof, around which overlay first and second parts 26 A, 26 B extend, from a distal portion thereof, about which coiled proximal end 312 is mounted.
- the junction portion provided by overlay first part 26 A is shown including a plurality of protrusions 263 longitudinally spaced apart from one another, which may facilitate the bonding of distal subassembly 320 thereto.
- FIG. 3 is an exploded perspective view of connector assembly 120 , in conjunction with an inner assembly of a medical electrical lead, for example, like lead 100 of FIG. 1A , according to some embodiments, wherein the inner assembly includes the aforementioned terminal connector pin 110 received within a retainer 360 and coupled to first elongate conductor 301 .
- the inner assembly includes the aforementioned terminal connector pin 110 received within a retainer 360 and coupled to first elongate conductor 301 .
- insulation segment 25 of proximal subassembly 210 includes an inner surface that defines a proximal lumen 250 extending along axis 2
- shank 278 of conductor segment 27 includes an inner surface that defines a distal lumen 270 , also extending along axis 2 and in fluid communication with proximal lumen 250 , wherein lumens 250 , 270 allow passage of conductor 301 through subassembly 210 , as is illustrated in FIG. 3 .
- proximal lumen 250 includes an enlarged bore 251 and a counter bore 252 , which forms an opening located at proximal end 121 of connector assembly 120 , wherein bore 251 is sized to receive a plug 361 of retainer 360 , for bonding thereto, when counter bore 252 receives a flange 362 of retainer 360 , for example, as shown in FIG. 4B .
- bore 251 has a diameter of approximately 0.075 inch (1.9 mm)
- counter bore 252 has a diameter of approximately 0.090 inch (2.3 mm), wherein an outer surface of retainer plug 361 is lobed for an interference fit within bore 251 , according to some embodiments.
- distal subassembly 320 includes third contact surface cs 3 , which extends between third and fourth sealing surfaces ss 3 , ss 4 ; distal assembly 320 is located for the assembling thereof around coiled proximal end 312 of conductor 302 , such that shank 278 of subassembly 210 is nested beneath sealing surfaces ss 3 , ss 4 and contact surface cs 3 , for example, as illustrated in the cross-section view of FIG. 4B .
- FIG. 4A is a longitudinal cross-section view of subassembly 320 , according to some embodiments, wherein third and fourth sealing surfaces ss 3 , ss 4 are shown formed by an insulation segment 45 , and third contact surface cs 3 is shown formed by a conductor segment 47 .
- FIG. 4A is a longitudinal cross-section view of subassembly 320 , according to some embodiments, wherein third and fourth sealing surfaces ss 3 , ss 4 are shown formed by an insulation segment 45 , and third contact surface cs 3 is shown formed by a conductor segment 47 .
- FIG. 4A illustrates an entirety of each of third and fourth sealing surfaces ss 3 , ss 4 and third contact surface cs 3 defining uniform outer diameter D; and, according to some preferred embodiments, insulation segment 45 is a bulk of insulative material, for example, any one of the aforementioned plastic materials mentioned above for insulative segment 25 , that is injection molded around conductor segment 47 , wherein conductor segment 47 is a metallic component, for example, formed from MP35N alloy or medical grade stainless steel.
- FIG. 4A further illustrates insulation segment 45 including an inner surface 455 extending beneath third sealing surface ss 3 , wherein inner surface 455 is preferably sized for bonding around insulative overlay first part 26 A of subassembly 210 , as shown in FIG. 4B , such that uniform outer diameter D is maintained for an entirety of connector assembly 120 .
- insulation segment 45 of subassembly 320 further includes a distal junction portion 46 which has an exterior surface configured for a junction of an overlapping portion of an insulative sleeve of a medical electrical lead, for example, a connector sleeve 146 of lead 100 , which is shown in FIG. 1A extending distally from a distal end 126 of connector assembly 120 and along at least a portion of transition zone 140 .
- FIG. 4A further illustrates an optional strain relief tubing 406 extending distally from junction portion 46 , wherein tubing 406 has a proximal end that extends within junction portion 46 and is coupled to an interior surface thereof.
- tubing 406 is formed from a medical grade polyurethane, and may be either insert molded into subassembly 320 or bonded thereto, for example, with any suitable polyurethane adhesive known in the art.
- insulative sleeve 430 which is not shown in FIG. 3 , may be seen extending around coiled proximal end 312 of conductor 302 and around insulative overlay second part 26 B.
- sleeve 430 may be an outer insulation layer of lead body 130 ( FIG. 1A ), for example, formed from a medical grade polyurethane, which is bonded to overlay second part 26 B with any suitable polyurethane adhesive known in the art.
- conductor segment 47 is isolated within insulation segment 45 such that third contact surface cs 3 is inactive, thus, the embodiment of connector assembly 120 that includes distal subassembly 320 is incorporated by a bipolar lead, which may be similar to lead 100 of FIG. 1 , but without third conductor 303 and second high voltage stimulation electrode hse 2 .
- FIG. 4B illustrates the inner assembly of the lead (introduced above, in conjunction with FIG. 3 ) further including another insulative sleeve 41 , which is not shown in FIG. 3 , but which extends around conductor 301 and alongside a channel 253 , which is formed in the inner surface of insulation segment 25 .
- Sleeve 41 electrically isolates conductor 301 from shank 278 and coiled proximal end 312 of conductor 302 , and provides redundant electrical isolation for contact surfaces cs 1 , cs 2 .
- Insulative sleeve 41 may be an inner insulation layer that extends along almost an entire length of conductor 301 ; as such, sleeve 41 may be formed from a fluoropolymer liner overlaid by medical grade silicone or polyurethane, according to some embodiments.
- channel 253 is shown offset from the opening at proximal end 121 and extending distally from counter bore 252 , alongside lumen 250 , being in fluid communication therewith.
- Channel 253 may have a round axial cross-section, as shown in FIG. 2B , for example, which has a diameter of approximately 0.022 inch (0.56 mm).
- channel 253 provides access for a needle port of a syringe so that adhesive, for example, silicone medical adhesive, or polyurethane adhesive, may be dispensed therethrough and between the inner surface of insulation segment 25 and insulative sleeve 41 , to bond sleeve 41 to subassembly 210 .
- adhesive for example, silicone medical adhesive, or polyurethane adhesive
- a shoulder 403 is formed at distal end of channel 253 to provide a stop for the needle port, thereby preventing inadvertent shutoff of the port by needle over-insertion.
- FIG. 5 is a perspective view of a distal subassembly 520 , as an alternative to distal subassembly 320 , in an alternate embodiment of connector assembly 120 , wherein third contact surface cs 3 is active and electrically coupled to third conductor 303 of the configuration of medical electrical lead 100 that includes the optional second stimulation electrode hse 2 ( FIG. 1 ).
- FIG. 5 illustrates distal subassembly 520 including an insulation segment 55 and a conductor segment 57 , wherein insulation segment 55 includes third and fourth sealing surfaces ss 3 , ss 4 , and conductor segment 57 includes third contact surface cs 3 and a distal shank 578 , which is electrically common with third contact surface cs 3 .
- FIG. 5 illustrates distal subassembly 520 including an insulation segment 55 and a conductor segment 57 , wherein insulation segment 55 includes third and fourth sealing surfaces ss 3 , ss 4 , and conductor segment 57 includes third
- insulation segment 55 is a bulk of insulative material, for example, any of the aforementioned exemplary plastics noted for insulative segment 25 of subassembly 210 , that is injection molded around conductor segment 57 , wherein conductor segment 47 is a metallic component, for example, formed from MP35N alloy or medical grade stainless steel, such that third contact surface cs 3 and distal shank 578 are integrally formed.
- Distal shank 578 includes a proximal portion, which is shown with dashed lines, that extends distally from third contact surface cs 3 , beneath fourth sealing surface ss 4 , and a distal portion 508 , which may have a tapering profile, and has a smaller diameter than uniform outer diameter D.
- the diameter of the distal portion 508 of shank 578 is sized to receive a coiled proximal end of third conductor 303 ( FIG. 1 ) mounted thereabout, in order to couple third conductor 303 to third contact segment cs 3 , for example, in a similar fashion to the mounting of proximal end 312 of second conductor 302 about shank 278 of subassembly 210 , as shown in FIGS.
- connector sleeve 146 extends over the coiled proximal end of third conductor 303 and may be bonded to a distal surface 56 of insulation segment 55 .
- FIG. 6 is an exploded perspective view of a connector assembly, according to some alternate embodiments suitable for a medical electrical lead with true bipolar sensing, for example, as described above, in conjunction with FIG. 1B .
- the connector assembly includes a proximal subassembly 610 and a middle subassembly 650 , which are positioned and sized for a nesting assembly together with one another, and with one of the two above-described distal subassemblies 320 , 520 .
- FIG. 6 is an exploded perspective view of a connector assembly, according to some alternate embodiments suitable for a medical electrical lead with true bipolar sensing, for example, as described above, in conjunction with FIG. 1B .
- the connector assembly includes a proximal subassembly 610 and a middle subassembly 650 , which are positioned and sized for a nesting assembly together with one another, and with one of the two above-described distal subassemblies 320
- FIG. 6 illustrates each of proximal subassembly 610 and middle subassembly 650 including a corresponding insulation segment 615 , 655 and a corresponding conductive segment 617 , 657 , wherein each sealing surface ss 1 , ss 2 and a corresponding junction portion 661 , 665 is integrally formed from the corresponding bulk of insulative material (insulation segments 615 , 655 ), and each contact surface cs 1 , cs 2 is integrally formed and electrically common with a corresponding shank 681 , 685 , each of which has a proximal portion extending beneath the corresponding junction portion 661 , 665 (shown with dashed lines).
- FIG. 6 further illustrates the connector assembly including a first coiled conductor 601 , which is mounted around and coupled to a distal portion of shank 681 of proximal subassembly 610 , and a second coiled conductor 602 which is mounted around and coupled to a distal portion of shank 685 of middle subassembly 650 .
- the distal portion of each of shanks 681 , 685 may have a tapering profile to facilitate the mounting of the corresponding conductor 601 , 602 .
- each of coiled conductors 601 , 602 includes insulation for electrical isolation, for example, an insulative sleeve that extends around each and/or a jacket of insulation formed around individual wire filars thereof.
- a portion of a lumen of proximal subassembly 610 that extends beneath first sealing surface ss 1 may be configured like proximal lumen 250 of proximal subassembly 210 , for example, to accommodate the assembly therewith of terminal connector pin 110 , retainer 360 , conductor 301 and insulative sleeve 41 of the inner assembly described in conjunction with FIGS. 2C , 3 and 4 B.
- FIG. 6 illustrates a third coiled conductor 603 mounted around shank 578 of distal subassembly 520 , for example, to couple third contact surface cs 3 , via conductor 303 , to optional second high voltage stimulation electrode hse 2 in lead 100 of FIG.
- third sealing surface ss 3 of either distal subassembly 320 , 520 is bonded to junction portion 665 of middle subassembly 650 so that third sealing surface ss 3 abuts second contact surface cs 2 , and an entirety of each of the first, second, and third contact surfaces cs 1 -cs 3 , and of each of the first, second, third, and fourth sealing surfaces ss 1 -ss 4 defines the above-described uniform outer diameter D for the connector assembly.
- optional strain relief tubing 406 may also be employed in conjunction therewith, as described above.
Abstract
Description
- The present disclosure pertains to implantable medical electrical leads, and more particularly to constructions of lead connector assemblies that are configured to mate with connector receptacles of corresponding implantable medical devices.
- Implantable medical systems, for example, those providing electrical stimulation for cardiac or neurological therapy, often include a pulse generator device and an elongate medical electrical lead that extends from the device to a stimulation site in a body of a patient. Numerous configurations of implantable medical electrical lead connectors have been disclosed over the years, many of which are directed toward compliance with international industry standards; these standards specify essential dimensions and performance requirements to assure compatibility of connection between pulse generator device connector receptacles and lead connectors among a variety of manufacturers. One such standard dictates the form for a four-pole in-line connector of cardiac pacing and defibrillation leads and is commonly known as the IS-4 or DF-4 standard.
-
FIG. 1A is a plan view of an exemplary implantable medicalelectrical lead 100, which includes aconnector assembly 120 and aterminal connector pin 110 that protrudes proximally from aproximal end 121 ofassembly 120 to form an in-line connector in conformance with the aforementioned DF-4 standard.FIG. 1A illustrateslead 100 including a low voltage distal-most electrode lde, a first high voltage stimulation electrode hse1, and a second, optional, high voltage stimulation electrode hse2. Distal-most electrode lde may be part of a passive fixation assembly, known in the art, as illustrated, or part of an active fixation assembly, which is also known in the art, and stimulation electrodes hse1, hse2 may each be formed from tantalum or platinum coils that extend around aninsulative body 130 oflead 100. Dashed lines inFIG. 1A representelongate conductors lead body 130, through aconnector transition zone 140 and intoconnector assembly 120.Lead body 130 andtransition zone 140 are configured to electrically isolate conductors 301-303 from one another and may be formed from medical grade silicone and/or polyurethane. The coupling of each electrode lde, hse1, hse2 to thecorresponding conductor FIG. 1A also shows a dot onconnector pin 110 and on each of contact surfaces cs1-cs3 to represent an electrical coupling with the corresponding conductor 301-303. - According to
FIG. 1A ,conductor 301 couples distal-most electrode lde toconnector pin 110, andconductor 302 couples stimulation electrode hse1 to both first and second contact surfaces cs1, cs2, such thatlead 100 provides integrated bipolar pacing and sensing via electrodes lde and hse1, in addition to high voltage defibrillation stimulation via electrode hse1 (and electrode hse2, by the coupling to contact surface cs3, if electrode hse2 and thecorresponding conductor 303 are included). Sealing surfaces ss1, ss2, ss3, ss4 are shown extending betweenconnector pin 110 and contact surface cs1, between contact surfaces cs1 and cs2, between contact surfaces cs2 and cs3, and between contact surface cs3 andtransition zone 140, respectively. - Those skilled in the art understand that
pin 110 and contact surfaces cs1-cs3 are configured to mate with device contacts mounted within a connector receptacle of the device, and sealing surfaces ss1-ss4 are configured to mate with sealing rings, which are interspersed between the contacts within the device connector receptacle, so that an electrical coupling is made between each device contact and the corresponding pin/contact surface, within the receptacle, and these couplings are electrically isolated from one another by the sealing rings. According to the DF-4 standard,pin 110 and first contact surface cs1 are designated low voltage contacts, and second and third contact surfaces cs2, cs3 are designated high voltage contacts. The DF-4 standard also requires a specific configuration ofterminal connector pin 110 and a uniform outer diameter D ofconnector assembly 120. Iflead 100 does not include second stimulation electrode hse2 andcorresponding conductor 303, the DF-4 standard still requires the presence of third contact surface cs3, albeit inactive, to preserve the standard form ofconnector assembly 120. According toFIG. 1A , first contact surface cs1 and second contact surface cs2 ofexemplary lead 100 are electrically common with one another for the aforementioned integrated function of electrode hse1 (e.g., to function as a low voltage pace/sense electrode and as a high voltage stimulation electrode). However, with reference toFIG. 1B , iflead 100 is reconfigured to include another low voltage electrode for true bipolar pacing and sensing in conjunction with distal-most electrode lde, for example, a ring electrode le shown extending aroundlead body 130, just proximal to electrode lde, another conductor (not shown) extends withinlead body 130, and electrically couples low voltage electrode le to first contact surface cs1. In this case,second conductor 302 is only electrically coupled to second contact surface cs2, and first and second contact surfaces cs1 and cs2 are not electrically common, being isolated from one another. - Although a variety of constructions for implantable medical electrical lead connector assemblies, which are similar to that described above, are known in the art, there is still a need for new constructions of lead connector assemblies that simplify the assembly process thereof to increase manufacturing efficiency and reduce cost.
- Various constructions of a connector assembly for an implantable medical electrical lead, which are disclosed herein, include an insulation segment and a conductor segment, wherein, according to some embodiments, the insulation segment includes first and second sealing surfaces and the conductor segment includes first and second contact surfaces and a shank, which extends distally from the second contact surface, and which is electrically common with the first and second contact surfaces. The insulation and conductor segments may be formed together in a molded subassembly. The first sealing surface extends distally from a proximal end of the connector assembly, the first contact surface extends between the first and second sealing surfaces, and the second contact surface extends distally from the second sealing surface, wherein an entirety of each of the sealing surfaces and of each of the contact surfaces define a uniform outer diameter of the connector assembly, which uniform outer diameter conforms to a requirement (e.g., an industry standard) for mating with a connector receptacle of an implantable medical device. The shank of the conductor segment has an outer diameter that is smaller than the uniform outer diameter of the assembly and is sized to receive a coiled proximal end of a conductor of the lead mounted thereabout for coupling to the connector assembly. The shank may be divided into a proximal portion and a distal portion, for example, by a flange of the shank, wherein the coiled proximal end of the conductor is mounted around the distal portion of the shank, and an insulative overlay extends around the proximal portion of the shank, for example, to provide an interface for a bond that joins the shank to another insulation segment, according to some construction embodiments. The other insulation segment includes a third sealing surface and an inner surface that extends beneath the third sealing surface and around the overlay for bonding thereto, such that an entirety of the third sealing surface also defines the uniform outer diameter of the connector assembly.
- A medical electrical lead with integrated bipolar pacing and sensing, according to some embodiments, includes the above-described connector assembly and a terminal connector pin, which protrudes from the proximal end thereof, being engaged within a proximal lumen of the connector assembly, wherein a first conductor of the lead is coupled to the pin and extends distally therefrom through the proximal lumen of the connector assembly and through a lumen of the shank, and a second conductor of the lead has the aforementioned coiled proximal end that is coupled to the connector assembly. The lead further includes a distal-most electrode, which is coupled to a distal end of the first conductor, and a stimulation electrode, which is coupled to a distal end of the second conductor.
- According to some embodiments, the above-described connector assembly further includes a third contact surface that is part of another conductor segment, wherein the aforementioned insulation segment that includes the third sealing surface also includes a fourth sealing surface, and the third contact surface extends between the third and fourth sealing surfaces. The other conductor segment and the corresponding insulation segment may be formed in a molded subassembly, according to some construction embodiments, and the shank of the above-described molded subassembly is nested beneath the third sealing surface, for bonding thereto, as described above. When this connector assembly that includes the third contact surface is incorporated by the above-described bipolar medical electrical lead, the third contact surface is inactive and electrically isolated from the conductors of the lead. But, according to some alternate embodiments of the connector assembly, for example, incorporated by a tripolar medical electrical lead, the other conductor segment further includes a distal shank that is electrically common with the third contact surface and extends distally therefrom, beneath the fourth sealing surface. The distal shank has an outer diameter that is smaller than the uniform outer diameter of the assembly, and is sized to receive a coiled proximal end of an elongate conductor of the lead mounted thereabout for coupling thereto. Thus, a tripolar lead, according to some embodiments, includes a third conductor and a corresponding stimulation electrode, in addition to the two electrodes and corresponding conductors described above, wherein the third conductor has the coiled proximal end coupled to the distal shank, and the distal shank includes an inner surface that defines a lumen through which the aforementioned second conductor extends to the coiled proximal end thereof, which is mounted about the other shank.
- Some additional embodiments of a connector assembly, which are disclosed herein, are configured for an implantable medical electrical lead with true bipolar pacing and sensing, have the aforementioned uniform outer diameter, and are constructed from three subassemblies as follows. A proximal subassembly of the connector assembly includes a first sealing surface, which extends distally from the proximal end of the connector assembly, a first contact surface, which extends distally from the first sealing surface, a first junction portion, which extends distally from the first contact surface, and a first shank, which extends distally from the first junction portion. A middle subassembly of the connector assembly includes a second sealing surface, a second contact surface, which extends distally from the second sealing surface, a second junction portion, which extends distally from the second contact surface, and a second shank, which extends distally from the second junction portion. The second sealing surface of the middle subassembly is bonded to the first junction portion of the proximal subassembly and abuts the first contact surface. A distal subassembly includes a third sealing surface and a third junction portion, wherein the third sealing surface is bonded to the second junction portion of the middle subassembly and abuts the second contact surface, and the third junction portion is configured for a junction with an insulative sleeve of the medical electrical lead. An entirety of the each of the first, second, and third sealing surfaces and of each the first and second contact surfaces define the uniform outer diameter of the connector assembly. Each of the first and second shanks is integrally formed and electrically common with the corresponding contact surface; and each of the first and second junction portions is integrally formed with the corresponding sealing surface in a corresponding bulk of insulative material. The first shank of the proximal subassembly extends within a lumen of the middle subassembly; and the second shank of the middle subassembly extends within a lumen of the distal subassembly. Embodiments of the connector assembly further include a first coiled conductor, which is mounted around and coupled to the first shank of the proximal subassembly, and a second coiled conductor, which is mounted around and coupled to the second shank of the middle subassembly.
- The following drawings are illustrative of particular embodiments of the present invention and therefore do not limit the scope of the invention. The drawings are not to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. Embodiments will hereinafter be described in conjunction with the appended drawings wherein like numerals/letters denote like elements, and:
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FIG. 1A is a plan view of an exemplary implantable medical electrical lead; -
FIG. 1B is a plan view of a distal portion of another exemplary implantable medical lead; -
FIGS. 2A-C are a plan view, an end view, and a cross-section view, respectively, of a portion of a connector assembly, according to some embodiments; -
FIG. 3 is an exploded perspective view of the connector assembly, according to some embodiments; -
FIG. 4A is a cross-section view of another portion of the connector assembly, according to some embodiments; -
FIG. 4B is a cross-section view of the connector assembly including the portion shown inFIG. 4A and assembled around an inner assembly of a medical electrical lead, according to some embodiments; -
FIG. 5 is a perspective view of another portion of the connector assembly, according to some alternate embodiments; and -
FIG. 6 is an exploded perspective view of a connector assembly, according to some alternate embodiments. - The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides practical examples, and those skilled in the art will recognize that some of the examples may have suitable alternatives.
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FIGS. 2A-C are a plan view, an end view, and a longitudinal cross-section view, respectively, of aproximal subassembly 210, according to some embodiments, which extends along alongitudinal axis 2, and which may be a portion of a connector assembly, like connector assembly 120 (FIG. 1 ). It should be noted, that although portions of exemplary embodiments of the present invention are described in the context ofconnector assembly 120, which conforms to the DF-4 standard, alternate embodiments of the present invention may include some of the described portions, without others, and need not conform to the DF-4 standard.FIG. 2B includes section lines A-A and B-B, wherein the cross-section view ofFIG. 2C corresponds to section line A-A, and the cross-section view ofFIG. 4B generally corresponds to section line B-B.FIGS. 2A and 2C illustrate subassembly 210 including aninsulation segment 25 and aconductor segment 27, whereininsulation segment 25 includes first sealing surface ss1 and second sealing surface ss2, and conductor segment includes first contact surface cs1, second contact surface cs2, and ashank 278, which extends distally from second contact surface cs2 and is electrically common with first and second contact surfaces cs1, cs2.FIGS. 2A and 2C further illustrate an entirety of each of the first and second sealing surfaces ss1, ss2 and each of the first and second contact surfaces cs1, cs2 defining the aforementioned uniform outer diameter D, which may be approximately 3.2 mm (0.126 inch). - According to some preferred embodiments,
insulation segment 25 is a bulk of insulative material, for example, a relatively hard plastic, such as Polyether ether ketone (PEEK), polyurethane, or polysulfone, that is injection molded aroundconductor segment 27, whereinconductor segment 27 is a metallic component, for example, having been machined from medical grade stainless steel or MP35N alloy, such that first and second contact surfaces cs1, cs2 andshank 278 are integrally formed. According to some embodiments and methods, an original outer diameter of portions of the metal component, which correspond to contact surfaces cs1, cs2, is larger than the uniform outer diameter D, so that recessed grooves in a mold cavity can hold the component in place while the aforementioned insulative material is injection molded thereabout. Then, following the molding process,subassembly 210 is ground down, for example, via a centerless grinding process known in the art, to the uniform outer diameter D. - A diameter of
shank 278 is smaller than diameter D, and, with reference toFIG. 3 , is sized to receive a coiledproximal end 312 of an elongate conductor coil mounted thereabout, for coupling to first and second contact surfaces cs1, cs2. With reference toFIG. 2A , the smaller outer diameter ofshank 278 has atapering profile 208, for example, to facilitate the mounting of coiledproximal end 312 thereabout. With reference back toFIG. 1 , according to some embodiments, coiledproximal end 312 is an integral extension ofconductor 302, or, according to some alternate embodiments, coiledproximal end 312 is coupled toconductor 302 withintransition zone 140, according to any suitable method known in the art. -
FIGS. 2A , 2C and 3 further illustrate an insulative overlay, which extends around a proximal portion ofshank 278, and which is divided into afirst part 26A and asecond part 26B. This overlay is preferably separately formed from the same insulative material asinsulation segment 25, wherein overlayfirst part 26A provides a junction portion, or an interface for bonding another part of the connector assembly, for example, a distal subassembly 320 (FIGS. 3 and 4B ), to subassembly 210, and overlaysecond part 26B provides a junction portion for attachment of an insulative sleeve 430 (FIG. 4B ), which, according to some preferred embodiments, is an outer insulation layer of an insulative lead body, for example, lead body 130 (FIG. 1A ).Distal subassembly 320 will be described in greater detail below.FIGS. 2A and 2C illustrateshank 278 including aflange 207, according to some embodiments, that separates the proximal portion thereof, around which overlay first andsecond parts proximal end 312 is mounted. The junction portion provided by overlayfirst part 26A is shown including a plurality ofprotrusions 263 longitudinally spaced apart from one another, which may facilitate the bonding ofdistal subassembly 320 thereto. -
FIG. 3 is an exploded perspective view ofconnector assembly 120, in conjunction with an inner assembly of a medical electrical lead, for example, likelead 100 ofFIG. 1A , according to some embodiments, wherein the inner assembly includes the aforementionedterminal connector pin 110 received within aretainer 360 and coupled to firstelongate conductor 301. With reference back toFIGS. 2A-C ,insulation segment 25 ofproximal subassembly 210 includes an inner surface that defines aproximal lumen 250 extending alongaxis 2, andshank 278 ofconductor segment 27 includes an inner surface that defines adistal lumen 270, also extending alongaxis 2 and in fluid communication withproximal lumen 250, whereinlumens conductor 301 throughsubassembly 210, as is illustrated inFIG. 3 . With reference back toFIG. 2C ,proximal lumen 250 includes anenlarged bore 251 and acounter bore 252, which forms an opening located atproximal end 121 ofconnector assembly 120, whereinbore 251 is sized to receive aplug 361 ofretainer 360, for bonding thereto, when counter bore 252 receives aflange 362 ofretainer 360, for example, as shown inFIG. 4B . According to an exemplary embodiment, bore 251 has a diameter of approximately 0.075 inch (1.9 mm), and counter bore 252 has a diameter of approximately 0.090 inch (2.3 mm), wherein an outer surface ofretainer plug 361 is lobed for an interference fit withinbore 251, according to some embodiments. - With further reference to
FIG. 3 ,distal subassembly 320 includes third contact surface cs3, which extends between third and fourth sealing surfaces ss3, ss4;distal assembly 320 is located for the assembling thereof around coiledproximal end 312 ofconductor 302, such thatshank 278 ofsubassembly 210 is nested beneath sealing surfaces ss3, ss4 and contact surface cs3, for example, as illustrated in the cross-section view ofFIG. 4B .FIG. 4A is a longitudinal cross-section view ofsubassembly 320, according to some embodiments, wherein third and fourth sealing surfaces ss3, ss4 are shown formed by aninsulation segment 45, and third contact surface cs3 is shown formed by aconductor segment 47.FIG. 4A illustrates an entirety of each of third and fourth sealing surfaces ss3, ss4 and third contact surface cs3 defining uniform outer diameter D; and, according to some preferred embodiments,insulation segment 45 is a bulk of insulative material, for example, any one of the aforementioned plastic materials mentioned above for insulativesegment 25, that is injection molded aroundconductor segment 47, whereinconductor segment 47 is a metallic component, for example, formed from MP35N alloy or medical grade stainless steel.FIG. 4A further illustratesinsulation segment 45 including aninner surface 455 extending beneath third sealing surface ss3, whereininner surface 455 is preferably sized for bonding around insulative overlayfirst part 26A ofsubassembly 210, as shown inFIG. 4B , such that uniform outer diameter D is maintained for an entirety ofconnector assembly 120. - With further reference to
FIG. 4A ,insulation segment 45 ofsubassembly 320 further includes adistal junction portion 46 which has an exterior surface configured for a junction of an overlapping portion of an insulative sleeve of a medical electrical lead, for example, aconnector sleeve 146 oflead 100, which is shown inFIG. 1A extending distally from adistal end 126 ofconnector assembly 120 and along at least a portion oftransition zone 140.FIG. 4A further illustrates an optionalstrain relief tubing 406 extending distally fromjunction portion 46, whereintubing 406 has a proximal end that extends withinjunction portion 46 and is coupled to an interior surface thereof. According to an exemplary embodiment,tubing 406 is formed from a medical grade polyurethane, and may be either insert molded intosubassembly 320 or bonded thereto, for example, with any suitable polyurethane adhesive known in the art. - With further reference to
FIG. 4B , the aforementionedinsulative sleeve 430, which is not shown inFIG. 3 , may be seen extending around coiledproximal end 312 ofconductor 302 and around insulative overlaysecond part 26B. As mentioned above,sleeve 430 may be an outer insulation layer of lead body 130 (FIG. 1A ), for example, formed from a medical grade polyurethane, which is bonded to overlaysecond part 26B with any suitable polyurethane adhesive known in the art. According to the illustrated embodiment,conductor segment 47 is isolated withininsulation segment 45 such that third contact surface cs3 is inactive, thus, the embodiment ofconnector assembly 120 that includesdistal subassembly 320 is incorporated by a bipolar lead, which may be similar to lead 100 ofFIG. 1 , but withoutthird conductor 303 and second high voltage stimulation electrode hse2. -
FIG. 4B illustrates the inner assembly of the lead (introduced above, in conjunction withFIG. 3 ) further including anotherinsulative sleeve 41, which is not shown inFIG. 3 , but which extends aroundconductor 301 and alongside achannel 253, which is formed in the inner surface ofinsulation segment 25.Sleeve 41 electrically isolatesconductor 301 fromshank 278 and coiledproximal end 312 ofconductor 302, and provides redundant electrical isolation for contact surfaces cs1, cs2.Insulative sleeve 41 may be an inner insulation layer that extends along almost an entire length ofconductor 301; as such,sleeve 41 may be formed from a fluoropolymer liner overlaid by medical grade silicone or polyurethane, according to some embodiments. With reference back toFIG. 2C ,channel 253 is shown offset from the opening atproximal end 121 and extending distally from counter bore 252, alongsidelumen 250, being in fluid communication therewith.Channel 253 may have a round axial cross-section, as shown inFIG. 2B , for example, which has a diameter of approximately 0.022 inch (0.56 mm). According to the illustrated embodiment,channel 253 provides access for a needle port of a syringe so that adhesive, for example, silicone medical adhesive, or polyurethane adhesive, may be dispensed therethrough and between the inner surface ofinsulation segment 25 andinsulative sleeve 41, to bondsleeve 41 tosubassembly 210. With further reference toFIGS. 2C and 4B , according to some preferred embodiments, ashoulder 403 is formed at distal end ofchannel 253 to provide a stop for the needle port, thereby preventing inadvertent shutoff of the port by needle over-insertion. -
FIG. 5 is a perspective view of adistal subassembly 520, as an alternative todistal subassembly 320, in an alternate embodiment ofconnector assembly 120, wherein third contact surface cs3 is active and electrically coupled tothird conductor 303 of the configuration of medicalelectrical lead 100 that includes the optional second stimulation electrode hse2 (FIG. 1 ).FIG. 5 illustratesdistal subassembly 520 including aninsulation segment 55 and aconductor segment 57, whereininsulation segment 55 includes third and fourth sealing surfaces ss3, ss4, andconductor segment 57 includes third contact surface cs3 and adistal shank 578, which is electrically common with third contact surface cs3.FIG. 5 illustrates an entirety of each of third and fourth sealing surfaces ss3, ss4 and third contact surface cs3 defining uniform outer diameter D; and, according to some preferred embodiments,insulation segment 55 is a bulk of insulative material, for example, any of the aforementioned exemplary plastics noted for insulativesegment 25 ofsubassembly 210, that is injection molded aroundconductor segment 57, whereinconductor segment 47 is a metallic component, for example, formed from MP35N alloy or medical grade stainless steel, such that third contact surface cs3 anddistal shank 578 are integrally formed.Distal shank 578 includes a proximal portion, which is shown with dashed lines, that extends distally from third contact surface cs3, beneath fourth sealing surface ss4, and adistal portion 508, which may have a tapering profile, and has a smaller diameter than uniform outer diameter D. The diameter of thedistal portion 508 ofshank 578 is sized to receive a coiled proximal end of third conductor 303 (FIG. 1 ) mounted thereabout, in order to couplethird conductor 303 to third contact segment cs3, for example, in a similar fashion to the mounting ofproximal end 312 ofsecond conductor 302 aboutshank 278 ofsubassembly 210, as shown inFIGS. 3 and 4B . Thus, with further reference toFIGS. 3 and 4B , whendistal subassembly 520 is substituted fordistal subassembly 320,connector sleeve 146 extends over the coiled proximal end ofthird conductor 303 and may be bonded to a distal surface 56 ofinsulation segment 55. -
FIG. 6 is an exploded perspective view of a connector assembly, according to some alternate embodiments suitable for a medical electrical lead with true bipolar sensing, for example, as described above, in conjunction withFIG. 1B . With reference toFIG. 6 , the connector assembly includes aproximal subassembly 610 and amiddle subassembly 650, which are positioned and sized for a nesting assembly together with one another, and with one of the two above-describeddistal subassemblies FIG. 6 illustrates each ofproximal subassembly 610 andmiddle subassembly 650 including acorresponding insulation segment conductive segment corresponding junction portion insulation segments 615, 655), and each contact surface cs1, cs2 is integrally formed and electrically common with acorresponding shank junction portion 661, 665 (shown with dashed lines).FIG. 6 further illustrates the connector assembly including a firstcoiled conductor 601, which is mounted around and coupled to a distal portion ofshank 681 ofproximal subassembly 610, and a secondcoiled conductor 602 which is mounted around and coupled to a distal portion ofshank 685 ofmiddle subassembly 650. Like the above-describedshanks shanks conductor - According to the illustrated embodiment, when
middle subassembly 650 is assembled together withproximal subassembly 610, second sealing surface ss2 is bonded tojunction portion 661 and abuts first contact surface cs1,shank 681 extends within a lumen ofmiddle subassembly 650, and firstcoiled conductor 601 extends within a lumen of secondcoiled conductor 602. Although not shown, each of coiledconductors FIG. 2C , a portion of a lumen ofproximal subassembly 610 that extends beneath first sealing surface ss1 may be configured likeproximal lumen 250 ofproximal subassembly 210, for example, to accommodate the assembly therewith ofterminal connector pin 110,retainer 360,conductor 301 andinsulative sleeve 41 of the inner assembly described in conjunction withFIGS. 2C , 3 and 4B. - With further reference to
FIG. 6 , when the connector assembly includesdistal subassembly 320, assembled per arrow A, adjacent tomiddle subassembly 650, third contact surface cs3 is inactive, as described above in conjunction withFIGS. 4A-B ; but, when the connector assembly includesdistal subassembly 520, assembled per arrow B, adjacent tomiddle subassembly 650, third contact surface cs3 is active.FIG. 6 illustrates a thirdcoiled conductor 603 mounted aroundshank 578 ofdistal subassembly 520, for example, to couple third contact surface cs3, viaconductor 303, to optional second high voltage stimulation electrode hse2 inlead 100 ofFIG. 1A , as described above in conjunction withFIG. 5 . In the completed connector assembly, third sealing surface ss3 of eitherdistal subassembly junction portion 665 ofmiddle subassembly 650 so that third sealing surface ss3 abuts second contact surface cs2, and an entirety of each of the first, second, and third contact surfaces cs1-cs3, and of each of the first, second, third, and fourth sealing surfaces ss1-ss4 defines the above-described uniform outer diameter D for the connector assembly. Finally, with reference back toFIG. 4A , whendistal subassembly 320 is employed in the connector assembly ofFIG. 6 , optionalstrain relief tubing 406 may also be employed in conjunction therewith, as described above. - In the foregoing detailed description, the invention has been described with reference to specific embodiments. However, it may be appreciated that various modifications and changes can be made without departing from the scope of the invention as set forth in the appended claims.
Claims (26)
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US14/133,899 US9106004B2 (en) | 2013-12-19 | 2013-12-19 | Implantable medical electrical leads and connector assemblies thereof |
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US20170291024A1 (en) * | 2015-12-15 | 2017-10-12 | Brainlab Ag | Guiding Tube for Stimulation Leads |
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US11338135B2 (en) | 2017-10-23 | 2022-05-24 | Cardiac Pacemakers, Inc. | Medical devices for cancer therapy with electric field shaping elements |
US11420049B2 (en) | 2019-04-22 | 2022-08-23 | Boston Scientific Scimed, Inc. | Systems for administering electrical stimulation to treat cancer |
US11691006B2 (en) | 2019-04-22 | 2023-07-04 | Boston Scientific Scimed, Inc. | Electrical stimulation devices for cancer treatment |
US11607542B2 (en) | 2019-04-23 | 2023-03-21 | Boston Scientific Scimed, Inc. | Electrical stimulation for cancer treatment with internal and external electrodes |
US11712561B2 (en) | 2019-04-23 | 2023-08-01 | Boston Scientific Scimed, Inc. | Electrical stimulation with thermal treatment or thermal monitoring |
US11850422B2 (en) | 2019-04-23 | 2023-12-26 | Boston Scientific Scimed, Inc. | Electrodes for electrical stimulation to treat cancer |
US11883655B2 (en) | 2020-02-24 | 2024-01-30 | Boston Scientific Scimed, Inc. | Systems and methods for treatment of pancreatic cancer |
Also Published As
Publication number | Publication date |
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WO2015094715A1 (en) | 2015-06-25 |
US9106004B2 (en) | 2015-08-11 |
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